ERCPPhase 3NCT00731198
Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During Endoscopic Retrograde Cholangiopancreatography (ERCP)
A Phase 3 study testing Drotaverine hydrochloride and Hyoscine-N-butylbromide in people with ERCP and Pancreatic Diseases, run by Changhai Hospital at 4 sites in China.
Trial summary
The aim of the present study was to evaluate the use of drotaverine hydrochloride versus hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- ERCP, Pancreatic Diseases, Bile Duct Diseases
- What is being tested?
- Drotaverine hydrochloride and Hyoscine-N-butylbromide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 4 sitesChina
- Study dates
- Aug 2008to Jul 2009
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients undergoing ERCP above the age of 18 years
Who cannot join
- Patient with Billroth II gastrectomy
- Known previous sphincterotomy
- Active acute pancreatitis before ERCP
- Ongoing acute cholangitis before ERCP
- Hypotension (systolic blood pressure < 100 mmHg)
- Second-degree and third-degree atrioventricular block
Show all 11Show fewer
- Heart failure
- Glaucoma
- Obstructive uropathy
- Impaired renal function (serum creatinine > 133μmol/L)
- Pregnant or breastfeeding women
Trial locations and contacts
4 sites in 1 country.
China4 sites
Fujian Provincial Hospital
Fuzhou
The First People's Hospital of Hangzhou
Hangzhou
Heilongjiang Provincial Hospital
Harbin
Changhai Hospital, Second Military Medical University
Shanghai
About this study
Official title: Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During ERCP: a Prospective, Multicenter Randomized Controlled Trial
The aim of the present study was to evaluate the use of drotaverine hydrochloride versus hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP.
Read the detailed description
ERCP is an important endoscopic technique in the diagnosis and treatment of pancreatic and biliary diseases. Duodenal peristalsis can make cannulation of the papilla and the necessary therapeutic procedures difficult. Intravenous hyoscine-N-butylbromide is often used during ERCP to inhibit duodenal motility and enhance cannulation in China. However, the pharmaceutical agent is occasionally associated with serious complications such as cardiovascular events or anaphylactic shock. Hyoscine-N-butylbromide may also affect the ocular, urinary, and salivary systems.
Drotaverine hydrochloride is an analogue of papaverine with smooth muscle relaxant properties. It is a non-anticholinergic antispasmodic, which selectively inhibits phosphodiesterase IV and is accompanied by a mild calcium channel-blocking effect. Adverse effects with drotaverine hydrochloride, such as hypotension, vertigo, nausea, and palpitation, are mostly mild. It can be supposed that intravenous drotaverine hydrochloride might be a feasible antimotility alternative to intravenous hyoscine-N-butylbromide in ERCP. But there is no clear evidence to recommend the use of drotaverine hydrochloride as an antispasmodic during ERCP.
The aim of the present study was to evaluate the use of drotaverine hydrochloride versus hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP. The effects of drotaverine hydrochloride on facilitative cannulation and its adverse effects were also compared to hyoscine-N-butylbromide.
- Conditions
- ERCP, Pancreatic Diseases, Bile Duct Diseases
- Being tested
- Drotaverine hydrochloride, Hyoscine-N-butylbromide
- Keywords
- ERCP, Drotaverine hydrochloride, Hyoscine-N-butylbromide
- Medical subject headings
- Pancreatic Diseases, Bile Duct Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drotaverine hydrochlorideDrug
Also called No-spa
Drotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP
Hyoscine-N-butylbromideDrug
Also called Scopolamine Butylbromide
Hyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Drotaverine hydrochloride Receives: Drug: Drotaverine hydrochloride |
| 2 | Active comparator | Hyoscine-N-butylbromide Receives: Drug: Hyoscine-N-butylbromide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Grades of the Number of Duodenal Contractions
a duodenal motility grade was determined as follows: 0 = no motility; 1 = less than five contractions/minute; 2 = 5 to 10/minute; 3 = 11 to 15/minute; 4 = continuous.
Measured: Intra-procedure
Secondary outcomes (4)
Cannulation Time
Measured: Intra-procedure
Percentage of Successful Selective Cannulation
Measured: Intra-procedure
Frequency of Post-ERCP Complications
Measured: 48 hours after ERCP
Side Effects
Measured: Intra-procedure and 24 hours after ERCP
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ERCPStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 650 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Zhaoshen Li, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00731198
- Sponsor's protocol ID
- Changhai-080615
- Status last verified
- Nov 2009
- First submitted
- 6 Aug 2008
- Last updated
- 8 Sep 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drotaverine Hydrochloride Versus Hyoscine-N-butylbromide for Duodenal Antimotility During ERCP: a Prospective, Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00731198
- Acronym / sponsor ID
- Changhai-080615
- Conditions
- ERCP, Pancreatic Diseases, Bile Duct Diseases
- Keywords
- ERCP, Drotaverine hydrochloride, Hyoscine-N-butylbromide
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 650 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 8 Aug 2008 (estimated)
- Results
- Posted 23 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study was to evaluate the use of drotaverine hydrochloride versus hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP.
Detailed description
ERCP is an important endoscopic technique in the diagnosis and treatment of pancreatic and biliary diseases. Duodenal peristalsis can make cannulation of the papilla and the necessary therapeutic procedures difficult. Intravenous hyoscine-N-butylbromide is often used during ERCP to inhibit duodenal motility and enhance cannulation in China. However, the pharmaceutical agent is occasionally associated with serious complications such as cardiovascular events or anaphylactic shock. Hyoscine-N-butylbromide may also affect the ocular, urinary, and salivary systems.
Drotaverine hydrochloride is an analogue of papaverine with smooth muscle relaxant properties. It is a non-anticholinergic antispasmodic, which selectively inhibits phosphodiesterase IV and is accompanied by a mild calcium channel-blocking effect. Adverse effects with drotaverine hydrochloride, such as hypotension, vertigo, nausea, and palpitation, are mostly mild. It can be supposed that intravenous drotaverine hydrochloride might be a feasible antimotility alternative to intravenous hyoscine-N-butylbromide in ERCP. But there is no clear evidence to recommend the use of drotaverine hydrochloride as an antispasmodic during ERCP.
The aim of the present study was to evaluate the use of drotaverine hydrochloride versus hyoscine-N-butylbromide in reducing duodenal motility during diagnostic and therapeutic ERCP. The effects of drotaverine hydrochloride on facilitative cannulation and its adverse effects were also compared to hyoscine-N-butylbromide.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Drotaverine hydrochlorideDrotaverine hydrochloride |
| 2 | Active comparator | Drug: Hyoscine-N-butylbromideHyoscine-N-butylbromide |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients undergoing ERCP above the age of 18 years
Key exclusion criteria (11 listed)
- Patient with Billroth II gastrectomy
- Known previous sphincterotomy
- Active acute pancreatitis before ERCP
- Ongoing acute cholangitis before ERCP
- Hypotension (systolic blood pressure < 100 mmHg)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drotaverine hydrochlorideAlso: No-spaDrotaverine hydrochloride 40mg was administered intravenously 15 minutes before ERCP | Drug | 1 |
| Hyoscine-N-butylbromideAlso: Scopolamine ButylbromideHyoscine-N-butylbromide 20mg was administered intravenously 15 minutes before ERCP. | Drug | 2 |
Primary outcome
The Grades of the Number of Duodenal Contractions
Time frame: Intra-procedure
a duodenal motility grade was determined as follows: 0 = no motility; 1 = less than five contractions/minute; 2 = 5 to 10/minute; 3 = 11 to 15/minute; 4 = continuous.
4 secondary outcomes
Cannulation Time
Time frame: Intra-procedure
Percentage of Successful Selective Cannulation
Time frame: Intra-procedure
Frequency of Post-ERCP Complications
Time frame: 48 hours after ERCP
Side Effects
Time frame: Intra-procedure and 24 hours after ERCP
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for ERCP
Not yet recruiting
Bispectral Index-Guided Propofol Sedation During Endoscopic Retrograde Cholangiopancreatography
Deep Sedation, Endoscopic Retrograde Cholangiopancreatography
RecruitingPhase 1
Metabolic Impact of Pancreatic Duct Decompression
Chronic Pancreatitis
Recruiting
Randomized Trial of Next Generation Fluoroscopy System vs. Conventional Fluoroscopy System in Endoscopy
Radiation Exposure
RecruitingPhase 3
Comparative Effectiveness Between Indomethacin and Pancreatic Stenting in the Prevention of Post ERCP Pancreatitis
Post ERCP Pancreatitis
Not yet recruiting
Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Post ERCP Pancreatitis, Acute Pancreatitis (AP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoshen Li, MD principal investigator
Changhai Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Drotaverine hydrochloride and Hyoscine-N-butylbromide in people with ERCP and Pancreatic Diseases, run by Changhai Hospital at 4 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Grades of the Number of Duodenal Contractions (time frame: Intra-procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2010.